Prostatic NeoplasmsNCT02651896
Hypofractionated Intensity Modulated and Image Guided Radiotherapy for Localized Prostate Cancer
An observational study of Prostatic Neoplasms, run by Hospital Sirio-Libanes at 2 sites in Brazil.
Trial summary
Hypofractionated intensity modulated and image guided radiotherapy (HypoIGRT) with fewer high-fraction-size treatments would be beneficial for prostate cancer because it would deliver a larger biological-equivalent dose to the tumor than would conventional treatment in 1.8-2.0 Gy fractions, while maintaining a similar… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- HypoIGRT
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- 2 sitesBrazil
- Study dates
- 20 Dec 2015to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men with localized histologically confirmed T1B-T4 N0 and M0 prostate cancer.
Who may be able to join
- Histologically confirmed, previously untreated locally confined adenocarcinoma of the prostate
- Patients older than 18 years old
- Patients who accept to perform follow up in the radiation oncology department
- Performance Status ≥ 70
- Written informed consent
Who cannot join
- Prior pelvic radiotherapy, radical prostatectomy, brachytherapy, cryotherapy or other local treatment
- Presenting with positive pelvic lymph nodes or metastatic at the diagnosis (M1)
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Hospital Sírio-Libanes
Brasília, Federal District, 71635-610
Rafael Gadia, MD, +556130447212, rafaelgadia@gmail.com
- Recruiting
Hospital Sírio-Libanes
São Paulo, São Paulo, 01308-050
Fabio Y Moraes, MD, +16472916646, fabio.ymoraes@hsl.org.br
Ana Cristina L Patrocinio, Graduated, +551133944797, ana.patrocinio@hsl.org.br
About this study
Official title: Hypofractionated Intensity Modulated and Image Guided Radiotherapy for Localized Prostate Cancer: a Prospective Cohort.
Hypofractionated intensity modulated and image guided radiotherapy (HypoIGRT) with fewer high-fraction-size treatments would be beneficial for prostate cancer because it would deliver a larger biological-equivalent dose to the tumor than would conventional treatment in 1.8-2.0 Gy fractions, while maintaining a similar or lower incidence of late normal tissue reactions. Thus, the investigators aim to assess the hypothesis that HypoIGRT treatment for localized prostate cancer will improve the therapeutic ratio by either:
- Reducing normal tissue, mainly genitourinary and gastrointestinal, toxicity and / or
- Improving tumour control, mainly freedom from biochemical failure survival.
Read the detailed description
The investigator chose to study a HypoIGRT regimen, in participants with prostate adenocarcinoma, tumor which is considered to present a low α / β, and therefore benefit from this approach.
Primary Outcome Measures:
- Acute and late radiation induced toxicities.
Secondary Outcome Measures:
- Freedom from prostate cancer recurrence - freedom from biochemical failure survival;
- Cause specific and overall survival
- Aspects of quality of life and health economics
Study Design:
Allocation: Prospective allocation Endpoint Classification: Feasibility Study (Toxicity assessment) Intervention Model: Single Assignment Masking: Open Label Primary Purpose: Treatment
Eligibility
Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No
Study Population:
Men with localized histologically confirmed T1B-T4 N0 and M0 prostate cancer.
- Conditions
- Prostatic Neoplasms
- Being tested
- HypoIGRT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypoIGRTRadiation
Hypofractionated intensity modulated and image guided radiotherapy 60 Gy in 20 fractions over four weeks for the prostate gland to all groups.
For intermediate and high risk group: seminal vesicle will be included: 48 Gy in 20 fractions over 4 weeks (proximal third to half on physicians description).
Image guidance with cone beam CT will be mandatory before every treatment fraction.
| Study group | Role | What they receive |
|---|---|---|
| HypoIGRT | 1. Low Risk (T1-T2a, Gleason score 6, and PSA < 10 ng/mL)
2. Intermediate Risk (T1-T2c, Gleason 7, and PSA 10-20 ng/mL)
3. High Risk (T3 - 4 , Gleason 8-10, and/or PSA > 20 ng/mL) Neoadjuvant hormone therapy is allowed on groups 2 and 3 Receives: Radiation: HypoIGRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Acute Gastrointestinal Toxicity - According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 - toxicity will be graduated in a scale from 0 - 5
Measured: During and up to 90 days after treatment ends (acute event)
Overall Acute Genitourinary Toxicity - According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 - toxicity will be graduated in a scale from 0 - 5
Measured: During and up to 90 days after treatment ends (acute event)
Overall Late Gastrointestinal Toxicity - According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 - toxicity will be graduated in a scale from 0 - 5.
Measured: After 90 days up to 24 months from treatment (late event)
Overall Late Genitourinary Toxicity - According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 - toxicity will be graduated in a scale from 0 - 5.
Measured: After 90 days up to 24 months from treatment (late event)
Secondary outcomes (4)
Freedom from biochemical failure survival
Prostate-Specific Antigen (PSA) values
Measured: 12 and 24 months
Overall Survival
Defined as the percentage of participant on treatment group who are alive at 12 and 24 months after the start of treatment.
Measured: 12 and 24 months
Cause specific Survival
Defined as the cancer survival in the absence of other causes of death at 12 and 24 months after the start of treatment.
Measured: 12 and 24 months
Quality of life
The Expanded Prostate Cancer Index Composite (EPIC) - Brazilian Portuguese version.
will be applied to assess urinary, bowel and sexual functions.
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study start20 Dec 2015
- Primary completion1 Jul 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Sirio-Libanes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael Gadia, Hospital Sirio-Libanes
- Investigators
- Luiz Reis, MD, PhD, Study director, Hospital Sírio-Libanes - Ensino e Pesquisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651896
- Sponsor's protocol ID
- HSL 2015-64
- Status last verified
- Aug 2017
- First submitted
- 6 Jan 2016
- Last updated
- 25 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chang P, Szymanski KM, Dunn RL, Chipman JJ, Litwin MS, Nguyen PL, Sweeney CJ, Cook R, Wagner AA, DeWolf WC, Bubley GJ, Funches R, Aronovitz JA, Wei JT, Sanda MG. Expanded prostate cancer index composite for clinical practice: development and validation of a practical health related quality of life instrument for use in the routine clinical care of patients with prostate cancer. J Urol. 2011 Sep;186(3):865-72. doi: 10.1016/j.juro.2011.04.085. Epub 2011 Jul 23.
PubMed 21788038Leborgne F, Fowler J. Late outcomes following hypofractionated conformal radiotherapy vs. standard fractionation for localized prostate cancer: a nonrandomized contemporary comparison. Int J Radiat Oncol Biol Phys. 2009 Aug 1;74(5):1441-6. doi: 10.1016/j.ijrobp.2008.10.087. Epub 2009 Apr 22.
PubMed 19395194Moraes FY, Siqueira GM, Abreu CE, da Silva JL, Gadia R. Hypofractioned radiotherapy in prostate cancer: is it the next step? Expert Rev Anticancer Ther. 2014 Nov;14(11):1271-6. doi: 10.1586/14737140.2014.972380.
PubMed 25367322Dearnaley D, Syndikus I, Sumo G, Bidmead M, Bloomfield D, Clark C, Gao A, Hassan S, Horwich A, Huddart R, Khoo V, Kirkbride P, Mayles H, Mayles P, Naismith O, Parker C, Patterson H, Russell M, Scrase C, South C, Staffurth J, Hall E. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: preliminary safety results from the CHHiP randomised controlled trial. Lancet Oncol. 2012 Jan;13(1):43-54. doi: 10.1016/S1470-2045(11)70293-5. Epub 2011 Dec 12.
PubMed 22169269
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated Intensity Modulated and Image Guided Radiotherapy for Localized Prostate Cancer: a Prospective Cohort.
- ClinicalTrials.gov ID
- NCT02651896
- Acronym / sponsor ID
- HSL 2015-64
- Conditions
- Prostatic Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Hospital Sirio-LibanesUniversity, hospital or other
- Study start
- 20 Dec 2015 (actual)
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 11 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypofractionated intensity modulated and image guided radiotherapy (HypoIGRT) with fewer high-fraction-size treatments would be beneficial for prostate cancer because it would deliver a larger biological-equivalent dose to the tumor than would conventional treatment in 1.8-2.0 Gy fractions, while maintaining a similar or lower incidence of late normal tissue reactions. Thus, the investigators aim to assess the hypothesis that HypoIGRT treatment for localized prostate cancer will improve the therapeutic ratio by either:
- Reducing normal tissue, mainly genitourinary and gastrointestinal, toxicity and / or
- Improving tumour control, mainly freedom from biochemical failure survival.
Detailed description
The investigator chose to study a HypoIGRT regimen, in participants with prostate adenocarcinoma, tumor which is considered to present a low α / β, and therefore benefit from this approach.
Primary Outcome Measures:
- Acute and late radiation induced toxicities.
Secondary Outcome Measures:
- Freedom from prostate cancer recurrence - freedom from biochemical failure survival;
- Cause specific and overall survival
- Aspects of quality of life and health economics
Study Design:
Allocation: Prospective allocation Endpoint Classification: Feasibility Study (Toxicity assessment) Intervention Model: Single Assignment Masking: Open Label Primary Purpose: Treatment
Eligibility
Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No
Study Population:
Men with localized histologically confirmed T1B-T4 N0 and M0 prostate cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HypoIGRT | – | Radiation: HypoIGRT1. Low Risk (T1-T2a, Gleason score 6, and PSA < 10 ng/mL) 2. Intermediate Risk (T1-T2c, Gleason 7, and PSA 10-20 ng/mL) 3. High Risk (T3 - 4 , Gleason 8-10, and/or PSA > 20 ng/mL) Neoadjuvant hormone therapy is allowed on groups 2 and 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men with localized histologically confirmed T1B-T4 N0 and M0 prostate cancer.
Key inclusion criteria (5 listed)
- Histologically confirmed, previously untreated locally confined adenocarcinoma of the prostate
- Patients older than 18 years old
- Patients who accept to perform follow up in the radiation oncology department
- Performance Status ≥ 70
- Written informed consent
Key exclusion criteria (2 listed)
- Prior pelvic radiotherapy, radical prostatectomy, brachytherapy, cryotherapy or other local treatment
- Presenting with positive pelvic lymph nodes or metastatic at the diagnosis (M1)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypoIGRTHypofractionated intensity modulated and image guided radiotherapy 60 Gy in 20 fractions over four weeks for the prostate gland to all groups. For intermediate and high risk group: seminal vesicle will be included: 48 Gy in 20 fractions over 4 weeks (proximal third to half on physicians description). Image guidance with cone beam CT will be mandatory before every treatment fraction. | Radiation | HypoIGRT |
Primary outcome
Overall Acute Gastrointestinal Toxicity - According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
Time frame: During and up to 90 days after treatment ends (acute event)
According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 - toxicity will be graduated in a scale from 0 - 5
Overall Acute Genitourinary Toxicity - According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
Time frame: During and up to 90 days after treatment ends (acute event)
According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 - toxicity will be graduated in a scale from 0 - 5
Overall Late Gastrointestinal Toxicity - According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
Time frame: After 90 days up to 24 months from treatment (late event)
According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 - toxicity will be graduated in a scale from 0 - 5.
Overall Late Genitourinary Toxicity - According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
Time frame: After 90 days up to 24 months from treatment (late event)
According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 - toxicity will be graduated in a scale from 0 - 5.
4 secondary outcomes
Freedom from biochemical failure survival
Time frame: 12 and 24 months
Overall Survival
Time frame: 12 and 24 months
Cause specific Survival
Time frame: 12 and 24 months
Quality of life
Time frame: 12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2017.
- Background: PubMed 21788038Chang P, Szymanski KM, Dunn RL, Chipman JJ, Litwin MS, Nguyen PL, Sweeney CJ, Cook R, Wagner AA, DeWolf WC, Bubley GJ, Funches R, Aronovitz JA, Wei JT, Sanda MG. Expanded prostate cancer index composite for clinical practice: development and validation of a practical health related quality of life instrument for use in the routine clinical care of patients with prostate cancer. J Urol. 2011 Sep;186(3):865-72. doi: 10.1016/j.juro.2011.04.085. Epub 2011 Jul 23.
- Background: PubMed 19395194Leborgne F, Fowler J. Late outcomes following hypofractionated conformal radiotherapy vs. standard fractionation for localized prostate cancer: a nonrandomized contemporary comparison. Int J Radiat Oncol Biol Phys. 2009 Aug 1;74(5):1441-6. doi: 10.1016/j.ijrobp.2008.10.087. Epub 2009 Apr 22.
- Background: PubMed 25367322Moraes FY, Siqueira GM, Abreu CE, da Silva JL, Gadia R. Hypofractioned radiotherapy in prostate cancer: is it the next step? Expert Rev Anticancer Ther. 2014 Nov;14(11):1271-6. doi: 10.1586/14737140.2014.972380.
- Background: PubMed 22169269Dearnaley D, Syndikus I, Sumo G, Bidmead M, Bloomfield D, Clark C, Gao A, Hassan S, Horwich A, Huddart R, Khoo V, Kirkbride P, Mayles H, Mayles P, Naismith O, Parker C, Patterson H, Russell M, Scrase C, South C, Staffurth J, Hall E. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: preliminary safety results from the CHHiP randomised controlled trial. Lancet Oncol. 2012 Jan;13(1):43-54. doi: 10.1016/S1470-2045(11)70293-5. Epub 2011 Dec 12.
- Protocol team hospital website.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luiz Reis, MD, PhD study director
Hospital Sírio-Libanes - Ensino e Pesquisa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms, run by Hospital Sirio-Libanes at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rafael Gadia, MD (+556130447212, rafaelgadia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Acute Gastrointestinal Toxicity - According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. (time frame: During and up to 90 days after treatment ends (acute event)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02651896, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2017.